2,810 datasets found

The Canada Vigilance Program is Health Canada's post-market surveillance program that collects and assesses reports of suspected adverse reactions to health products marketed in...

Information on risk management plan submissions for drugs including when to file, considerations, requirements, and compliance.

Health Canada assesses safety and nutritional adequacy of the following two types of infant foods: (1) infant formulas (human milk substitutes) and (2) human milk fortifiers,...

A pharmaceutical company that holds a compulsory licence under Canada's Access to Medicines Regime is required to pay royalties to the patent holder. The company must make...

Health Canada has notified Abbott Laboratories that it has no objection to the sale of their meal replacements and formulated liquid diets with added calcium 3-hydroxy-3-methyl...

Health Canada is offering an option for a rolling review of a new drug submission (NDS) or supplement to a new drug submission (SNDS) that meets specific eligibility conditions....

Anyone can report a side effect to a health or cannabis product. Report the issue as soon as possible after the reaction or problem occurred. You should do this even if you are...

The guidance is intended to advise both internal and external stakeholders regarding the filing requirements for postmarket changes and the data recommendations to support those...

The List of Contaminants and Other Adulterating Substances in Foods specifies an ML of 0.2 parts per million (p.p.m.) for lead in fruit juice, fruit nectar, beverages when...

Notice of Compliance with Conditions - Qualifying Notice

The purpose of this Cyclical Enforcement (CE) project was to verify industry’s compliance of consumer chemicals with the requirements of the Consumer Chemicals and Containers...

This guidance document supports Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (Interim Order No. 2).

There is an unprecedented demand and urgent need for access to drugs during the COVID-19 pandemic. On March 30, 2020, the Minister of Health signed the Interim Order Respecting...

Regulatory Initiative: Amendments to the Food and Drug Regulations Division 15 and 16 Clean Up for Food Additives - Forward Regulatory Plan 2015-2017

Depending on its ingredients, a dental plaque-disclosing product can be regulated as a drug under the F&DA either as a pharmaceutical drug subject to the Food and Drug...

A Notice of Compliance (NOC) is issued to a manufacturer following the satisfactory review of a submission for a new drug, and signifies compliance with the Food and Drug...

Health Canada's Medical Devices Regulations regulate traditional devices effectively. New technologies, such as software as a medical device, need more flexibility in our...

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in August 2023 by Health Canada.

Alberta has created a Virtual Care Action Plan to leverage this groundwork and move the province to the next level.

Pursuant to section 56 of the CDSA and subject to the terms and conditions set out herein, Registered Persons are exempted from the application of the following subsections of...